Corneal Confocal Microscopy in Patients With Type 1 Diabetes

Not Applicable

Withdrawn

• Conditions: Diabetic Neuropathies
• Interventions: Device: Corneal confocal microscopy; Procedure: Skin biopsy; Other: Blood draw; Procedure: Nerve conduction study

• Registration Number: NCT03045250
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.

Detailed Description

Rationale: Poorly controlled diabetes mellitus is associated with microvascular complications, which includes peripheral neuropathy. Peripheral neuropathy associated with diabetes is a painful condition. Its diagnosis is hampered by painful and long nerve conduction studies which fail to diagnose small nerve neuropathy. It is important to study methods of noninvasive methods of early detection, which are sensitive and specific in diagnosing early neuropathy and we propose a novel study that this can be detected in the cornea of the eye.

Aims:

* Estimate corneal small nerve fiber damage in young T1DM subjects (corneal fiber density, nerve branch density, and fiber length) and compare the results to healthy controls using corneal confocal microscopy (CCM).

* Estimate corneal nerve fiber damage in subjects with diabetes, with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsies and nerve conduction studies

* Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes.

* As a secondary outcome measure, to compare serum biomarkers including leptin, TNF alpha, and fibrinogen in patients with diabetes in those with neuropathy Vs. without neuropathy.

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-07
• Status Verified: 2018-08
• Study Start: 2018-08-01
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-09-04
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Blood draw	Healthy controls
Type 1 Diabetes	Corneal confocal microscopy	Subjects with known Type 1 diabetes
Healthy Controls	Corneal confocal microscopy	Healthy controls
Type 1 Diabetes	Nerve conduction study	Subjects with known Type 1 diabetes
Type 1 Diabetes	Skin biopsy	Subjects with known Type 1 diabetes
Healthy Controls	Nerve conduction study	Healthy controls
Type 1 Diabetes	Blood draw	Subjects with known Type 1 diabetes

Primary Outcome Measures

Name	Time	Method
Corneal small nerve fiber damage	Assessed one time per subject during study (study completed over 3 years)	Estimate corneal small nerve fiber damage in young T1DM subjects and compare the results to healthy controls using corneal confocal microscopy (CCM). This will be done by examining the cornea via confocal microscopy and obtaining images. These images will be evaluated looking at how many nerves there are, how they branch, and how long they are).
Normative values for corneal confocal microscopy (CCM)	Assessed one time per subject during study (study completed over 3 years)	Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes. This will be done by obtaining a small biopsy of skin and looking at the number of nerve fibers in the outer layer of the skin.

Secondary Outcome Measures

Name	Time	Method
Serum biomarkers - TNF Alpha	Assessed one time per subject during study (study completed over 3 years)	Measuring serum biomarkers (blood levels) Tumor Necrosis Factor (TNF) Alpha. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.
Serum biomarkers - fibrinogen	Assessed one time per subject during study (study completed over 3 years)	Measuring serum biomarkers (blood levels) fibrinogen. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.
Serum biomarkers - leptin	Assessed one time per subject during study (study completed over 3 years)	Measuring serum biomarkers (blood levels) leptin. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.